Vivasure Medical has recruited the first patients in its study of the PerQseal closure device system, which is designed for arteriotomies.
The PATCH clinical study, which is a multi-centre, single-arm, pivotal trial, will assess the system’s safety and efficacy.
Dr Vijay Iyer, University of Buffalo cardiology chief and Buffalo General Hospital structural heart interventions director enrolled the initial patients for the trials at Kaleida Health’s Buffalo General Medical Center-Gates Vascular Institute, located in Buffalo, New York.
In a statement, Dr Iyer said: “Large bore closure can be challenging and PerQseal is a promising technology for interventional cardiologists as a growing number of treatment options for patients utilise fully percutaneous approaches.”
The pivotal trial aims to recruit a maximum of 171 patients in the US, along with up to 90 patients at up to eight investigational sites in Europe.
The results of the study will be utilised for a pre-market approval submission to the US Food and Drug Administration (FDA).
PerQseal is claimed to be the first sutureless and fully absorbable synthetic implant for the closure of large-bore arterial vessel punctures.
Deploying the device from inside the vessel offers a simpler and more controlled approach compared to conventional closure techniques.
PerQseal PATCH study principal investigator Dr William Gray said: “With the recent proliferation of large bore arterial access, there’s a moment at the completion of each procedure when vessel management is critical and clinicians must quickly and effectively close it to reduce unnecessary, potentially life-threatening bleeding.
“I look forward to evaluating the PerQseal technology and its simplified, controlled technique – with the ultimate goal of reducing vascular complications for these patients.”